Medline Industries, LP: Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A

Recall number

Z-1414-2026

Recalling firm

Medline Industries, LP

Product

Medline Convenience Kits: 1) OB KIT, Model Number: DYKM2326; 2) KIT LABOR DELIVERY TUBAL LIGAT, Model Number: DYKMBNDL165; 3) KIT LABOR & DELIVERY D&C/D&E, Model Number: DYKMBNDL31; 4) KIT LABOR & DELIVERY CERCLAGE, Model Number: DYKMBNDL38; 5) L & D PACK-LF, Model Number: DYNJ0456816O; 6) L & D PACK-LF, Model Number: DYNJ0456816P; 7) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ04692S; 8) VAGINAL DELIVERY PACK, Model Number: DYNJ16621B; 9) VAGINAL DELIVERY PACK, Model Number: DYNJ16621C; 10) DELIVERY PACK-LF, Model Number: DYNJ20546F; 11) VAGINAL DELIVERY PK, Model Number: DYNJ20979I; 12) VAGINAL DELIVERY PK, Model Number: DYNJ20979J; 13) VAGINAL DELIVERY PACK, Model Number: DYNJ24108D; 14) OB PACK-LF, Model Number: DYNJ26121I; 15) OB DELIVERY PACK, Model Number: DYNJ31024J; 16) OB DELIVERY PACK-LF, Model Number: DYNJ32139C; 17) DB VAG HYSTERECTOMY-LF, Model Number: DYNJ33590F; 18) MAJOR VAGINAL PACK, Model Number: DYNJ35488F; 19) ENS. ACCOUCHEMENT VAGINAL-LF, Model Number: DYNJ37331C; 20) VAG DELIVERY PACK, Model Number: DYNJ38481G; 21) VAG DELIVERY PACK, Model Number: DYNJ38481I; 22) VAG DELIVERY PACK, Model Number: DYNJ38481K; 23) OB PACK 2, Model Number: DYNJ39000D; 24) GYNECOLOGY VAGINAL KIT, Model Number: DYNJ40203A; 25) LABOR DELIVERY POUCH SCREEN, Model Number: DYNJ40918A; 26) L & D PACK WITHOUT INSTRUMENTS, Model Number: DYNJ44720B; 27) VAGINAL DELIVERY PACK, Model Number: DYNJ51377G; 28) FH VAG DELIVERY PK-LF, Model Number: DYNJ51794B; 29) VAGINAL DELIVERY PACK, Model Number: DYNJ55363A; 30) VAGINAL DELIVERY PACK, Model Number: DYNJ55363B; 31) MINOR VAGINAL PACK, Model Number: DYNJ61269B; 32) OB VAG DELIVERY PACK, Model Number: DYNJ61574; 33) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ61650; 34) OB-VAG PACK 9128190, Model Number: DYNJ62341; 35) HP VAGINAL DELIVERY PACK-LF, Model Number: DYNJ62402A; 36) L & D PACK, Model Number: DYNJ63216A; 37) L&D PACK, Model Number: DYNJ63757A; 38) GYN PACK DYNJ55833A, Model Number: DYNJ65145; 39) MINOR VAG PACK, Model Number: DYNJ68663; 40) UTHET TYLER OB PACK, Model Number: DYNJ68673A; 41) GYN VAGINAL PACK, Model Number: DYNJ68681; 42) VAGINAL DELIVERY PACK, Model Number: DYNJ69544A; 43) VAGINAL PACK, Model Number: DYNJ69774A; 44) LABOR & DELIVERY PACK-LF, Model Number: DYNJ84393; 45) DELIVERY PACK, Model Number: DYNJ87469A; 46) VAGINAL DELIVERY, Model Number: DYNJ901387A; 47) FLOYD DELIVERY, Model Number: DYNJ906937D; 48) OB VAGINAL MEDSTAR PACK-LF, Model Number: DYNJT3445; 49) OB PACK, Model Number: DYNJT5186; 50) VAGINAL DELIVERY KIT, Model Number: MNS13550A; 51) VAGINAL DELIVERY TRAY, Model Number: MNS7460A; 52) LABOR AND DELIVERY KIT, Model Number: MNS8950A

Status

Open, Classified

Initiated

2026-01-07

Posted

2026-02-17

Terminated

not on file

Reason

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Root cause

Under Investigation by firm

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,

Quantity

27320 units

Distribution

Worldwide distribution - US Nationwide.

Lot, serial or model codes

1) DYKM2326, UDI-DI: 10198459565748(each), 40198459565749(case), Lot Number: 25KMF765; 2) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 24ABK386; 3) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBV905; 4) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23KBA329; 5) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23HBR548; 6) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23EBP170; 7) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 23BBT994; 8) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22LBB693; 9) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22KBS631; 10) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 22IBB499; 11) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21LBX453; 12) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21KBM483; 13) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21JBQ910; 14) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBO498; 15) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21IBE978; 16) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21GBN267; 17) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21FBP760; 18) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21EBE875; 19) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21DBA335; 20) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABT654; 21) DYKMBNDL165, UDI-DI: 10193489477405(each), 40193489477406(case), Lot Number: 21ABI982; 22) DYKMBNDL31, UDI-DI: 10193489478716(each), 40193489478717(case), Lot Number: 21ABC201; 23) DYKMBNDL38, UDI-DI: 10193489477757(each), 40193489477758(case), Lot Number: 21ABM087; 24) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JME434; 25) DYNJ0456816O, UDI-DI: 10195327435219(each), 40195327435210(case), Lot Number: 23JMC541; 26) DYNJ0456816P, UDI-DI: 10195327570545(each), 40195327570546(case), Lot Number: 24HMK119; 27) DYNJ04692S, UDI-DI: 10193489338454(each), 40193489338455(case), Lot Number: 21ADB239; 28) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25DMH878; 29) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25CME932; 30) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 25AME014; 31) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24JMB353; 32) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24IMF157; 33) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24GMJ484; 34) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24FMF250; 35) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24DMI443; 36) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24CMB999; 37) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 24BMA554; 38) DYNJ16621B, UDI-DI: 10195327558116(each), 40195327558117(case), Lot Number: 23KMJ818; 39) DYNJ16621C, UDI-DI: 10198459421297(each), 40198459421298(case), Lot Number: 25GMD428; 40) DYNJ20546F, UDI-DI: 10193489346084(each), 40193489346085(case), Lot Number: 22IMG976; 41) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22FMB686; 42) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22EMF465; 43) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22DMB332; 44) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22CME094; 45) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 22AMA608; 46) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21KMB071; 47) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21JMA483; 48) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21IMD851; 49) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21HMD738; 50) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21GMB531; 51) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21DMD921; 52) DYNJ20979I, UDI-DI: 10193489865905(each), 40193489865906(case), Lot Number: 21CME149; 53) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 23AMJ134; 54) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22LMA315; 55) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22IMH408; 56) DYNJ20979J, UDI-DI: 10195327191733(each), 40195327191734(case), Lot Number: 22GMH899; 57) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBS023; 58) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23IBA365; 59) DYNJ24108D, UDI-DI: 10195327425258(each), 40195327425259(case), Lot Number: 23GBU622; 60) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25IBJ589; 61) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25HBM068; 62) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25GBJ925; 63) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25FBE718; 64) DYNJ26121I, UDI-DI: 10198459329517(each), 40198459329518(case), Lot Number: 25EBA350; 65) DYNJ31024J, UDI-DI: 10195327139544(each), 40195327139545(case), Lot Number: 22IMF645; 66) DYNJ32139C, UDI-DI: 10193489588576(each), 40193489588577(case), Lot Number: 25DBK245; 67) DYNJ33590F, UDI-DI: 10193489220759(each), 40193489220750(case), Lot Number: 20LDC125; 68) DYNJ35488F, UDI-DI: 10193489803488(each), 40193489803489(case), Lot Number: 23JMB591; 69) DYNJ37331C, UDI-DI: 10889942670512(each), 40889942670513(case), Lot Number: 25GBN237; 70) DYNJ38481G, UDI-DI: 10193489727937(each), 40193489727938(case), Lot Number: 20LMD360; 71) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21LMB210; 72) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JME107; 73) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21JMC579; 74) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21IMB736; 75) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21GMB665; 76) DYNJ38481I, UDI-DI: 10193489825251(each), 40193489825252(case), Lot Number: 21DMB477; 77) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23IMD484; 78) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23HMC301; 79) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23GMD513; 80) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23EMD649; 81) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23CMF409; 82) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMJ499; 83) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC555; 84) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC551; 85) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 23AMC268; 86) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22IMG983; 87) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22GMH656; 88) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22EME995; 89) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMB285; 90) DYNJ38481K, UDI-DI: 10195327118242(each), 40195327118243(case), Lot Number: 22CMA009; 91) DYNJ39000D, UDI-DI: 10195327319656(each), 40195327319657(case), Lot Number: 23JMB120; 92) DYNJ40203A, UDI-DI: 10193489670998(each), 40193489670999(case), Lot Number: 21GDA744; 93) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23GBM044; 94) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23FBM020; 95) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23EBQ232; 96) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 23ABO451; 97) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22HBL591; 98) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22FBP490; 99) DYNJ40918A, UDI-DI: 10195327067847(each), 40195327067848(case), Lot Number: 22EBD699; 100) DYNJ44720B, UDI-DI: 10195327277512(each), 40195327277513(case), Lot Number: 23FDB511; 101) DYNJ51377G, UDI-DI: 10193489906325(each), 40193489906326(case), Lot Number: 23HBO866; 102) DYNJ51794B, UDI-DI: 10193489644708(each), 40193489644709(case), Lot Number: 21ADA465; 103) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22OBB980; 104) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22EBI837; 105) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW142; 106) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 22CBW139; 107) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21LBT403; 108) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21JBY447; 109) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21BBB866; 110) DYNJ55363A, UDI-DI: 10889942756742(each), 40889942756743(case), Lot Number: 21ABH443; 111) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23HBT039; 112) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23GBN972; 113) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23FBE833; 114) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23EBJ019; 115) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23CBA634; 116) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 23ABO534; 117) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22JBD960; 118) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22IBQ631; 119) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM755; 120) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBM753; 121) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22HBA092; 122) DYNJ55363B, UDI-DI: 10195327173548(each), 40195327173549(case), Lot Number: 22FBO672; 123) DYNJ61269B, UDI-DI: 10195327054687(each), 40195327054688(case), Lot Number: 22OBD693; 124) DYNJ61574, UDI-DI: 10193489601084(each), 40193489601085(case), Lot Number: 23BMF067; 125) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 23FBR019; 126) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 23DBL820; 127) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 22JBW013; 128) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 22HBT023; 129) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21VBA541; 130) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21LBT378; 131) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21LBT375; 132) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21KBV669; 133) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21IBA396; 134) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21GBK690; 135) DYNJ61650, UDI-DI: 10193489586053(each), 40193489586054(case), Lot Number: 21CBU863; 136) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23FDA173; 137) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23EDA759; 138) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23DDB664; 139) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 23BDA994; 140) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 22IDA469; 141) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 22EDB025; 142) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 22DDC251; 143) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21IDA188; 144) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21FDC626; 145) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21EDB976; 146) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 21BDC025; 147) DYNJ62341, UDI-DI: 10193489647020(each), 40193489647021(case), Lot Number: 20LDB518; 148) DYNJ62402A, UDI-DI: 10193489926132(each), 40193489926133(case), Lot Number: 23KBF906; 149) DYNJ62402A, UDI-DI: 10193489926132(each), 40193489926133(case), Lot Number: 23IBS478; 150) DYNJ62402A, UDI-DI: 10193489926132(each), 40193489926133(case), Lot Number: 23HBL396; 151) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25JBU638; 152) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25HBG200; 153) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25GBA096; 154) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25CBL912; 155) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 25ABR935; 156) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 24KBM262; 157) DYNJ63216A, UDI-DI: 10198459065125(each), 40198459065126(case), Lot Number: 24HBN118; 158) DYNJ63757A, UDI-DI: 10195327542481(each), 40195327542482(case), Lot Number: 23KBG966; 159) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 22DDA962; 160) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 21LDB251; 161) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 21KDA784; 162) DYNJ65145, UDI-DI: 10193489247848(each), 40193489247849(case), Lot Number: 21IDB501; 163) DYNJ68663, UDI-DI: 10193489837346(each), 40193489837347(case), Lot Number: 21LBB336; 164) DYNJ68673A, UDI-DI: 10198459221712(each), 40198459221713(case), Lot Number: 25GBC048; 165) DYNJ68681, UDI-DI: 10193489840209(each), 40193489840200(case), Lot Number: 22ABN829; 166) DYNJ69544A, UDI-DI: 10195327325367(each), 40195327325368(case), Lot Number: 25DBK232; 167) DYNJ69774A, UDI-DI: 10195327328368(each), 40195327328369(case), Lot Number: 23KBM418; 168) DYNJ69774A, UDI-DI: 10195327328368(each), 40195327328369(case), Lot Number: 23IBU502; 169) DYNJ84393, UDI-DI: 10195327361990(each), 40195327361991(case), Lot Number: 25HMC554; 170) DYNJ87469A, UDI-DI: 10198459336522(each), 40198459336523(case), Lot Number: 25GBV520; 171) DYNJ901387A, UDI-DI: 10193489707922(each), 40193489707923(case), Lot Number: 24IBP827; 172) DYNJ906937D, UDI-DI: 10193489963335(each), 40193489963336(case), Lot Number: 23HBQ793; 173) DYNJ906937D, UDI-DI: 10193489963335(each), 40193489963336(case), Lot Number: 23GBV967; 174) DYNJ906937D, UDI-DI: 10193489963335(each), 40193489963336(case), Lot Number: 23EBU945; 175) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25JBR855; 176) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25IBO981; 177) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25IBD649; 178) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25HBO297; 179) DYNJT3445, UDI-DI: 10198459325175(each), 40198459325176(case), Lot Number: 25EBI391; 180) DYNJT5186, UDI-DI: 10198459468797(each), 40198459468798(case), Lot Number: 25HBM919; 181) MNS13550A, UDI-DI: 10653160992875(each), 40653160992876(case), Lot Number: 25DBJ182; 182) MNS13550A, UDI-DI: 10653160992875(each), 40653160992876(case), Lot Number: 23JBU943; 183) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 25DBK156; 184) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 25ABQ083; 185) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 25ABJ839; 186) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24JBU227; 187) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24IBC061; 188) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24HBA805; 189) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24GBK561; 190) MNS7460A, UDI-DI: 10653160996392(each), 40653160996393(case), Lot Number: 24CBN067; 191) MNS8950A, UDI-DI: 10653160320388(each), 40653160320389(case), Lot Number: 21GBG870

510(k) numbers

not on file

PMA numbers

not on file

Product code

MLS

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 3e6df46828c1, published 2026-10-06

Copy